Percutaneous blepharoplasty device and method
Approaches for percutaneous blepharoplasty are provided. An electrosurgical device includes: a hand-piece; a tip connected to the hand-piece; and two needles extending from a distal end of the tip. The hand-piece is structured and arranged to connect to an electrical energy source, and to convey electrical energy from the electrical energy source to the needles in a percutaneous blepharoplasty procedure.
This application claims domestic priority to U.S. Provisional Patent Application No. 61/847,218 filed Jul. 17, 2013, the contents of which are incorporated by reference in their entirety.
FIELD OF THE INVENTIONThe invention generally relates to medical devices and associated methods of manufacture and use, and more particularly to electrosurgical devices and associated methods of manufacture and use.
BACKGROUNDBlepharoplasty is the plastic surgery operation for correcting defects, deformities and/or disfigurations of the eyelids. Excess deposits of eyelid fat can result in the appearance of puffiness around the eyes. The removal of this excess fat improves the overall look of the eyes, resulting in a more youthful and rested appearance of the individual.
Typically this procedure is done using one of two methods. The eyelid may be retracted to expose the underlying fat, which may then be removed using a number of different techniques. Alternatively, an incision may be made horizontally across the length of the eyelid to expose the fat pads underneath. Both of these methods utilize an incision and local anesthesia, and the incision may result in a scar.
SUMMARYIn a first aspect of the invention, there is a device, comprising a handle, two small parallel needle tips and an attachment means to an electrosurgical generator unit. The device is adapted to utilize bipolar electrosurgery with one of the needles serving as the active electrode and the other needle representing the return electrode. The device is adapted such that the electrosurgical current travels through the active electrode, passes through the tissue between the needle tips and run into the return electrode. During this process, the tissue shrinks and/or retracts as a result of the electrosurgical current.
The present invention is described in the detailed description which follows, in reference to the noted plurality of drawings by way of non-limiting examples of exemplary embodiments of the present invention.
The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show structural details of the present invention in more detail than is necessary for the fundamental understanding of the present invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the present invention may be embodied in practice.
The invention generally relates to medical devices and associated methods of manufacture and use, and more particularly to electrosurgical devices and associated methods of manufacture and use. In accordance with aspects of the invention, there is an electrosurgical device that is configured for performing a percutaneous blepharoplasty procedure. In surgery, and as used herein, the term “percutaneous” pertains to a medical procedure where access to inner organs or other tissue is done via needle-puncture of the skin, rather than by using an open approach where inner organs or tissue are exposed via an incision (e.g., a scalpel incision). Implementations of the invention allow for a blepharoplasty procedure to be done percutaneously, without the use of anesthesia or requiring any incisions. Using a percutaneous blepharoplasty procedure according to aspects of the invention advantageously results in reduced procedural time and minimizes or eliminates bleeding and scarring relative to other types of blepharoplasty procedure that involve incisions.
In embodiments, an electrosurgical device includes a handle, two small parallel needle tips, and an attachment means to an electrosurgical generator unit. The device may utilize bipolar electrosurgery with one of the needles serving as the active electrode and the other needle representing the return electrode. In embodiments, the electrosurgical current travels through the active electrode, passes through the fat tissue between the needle tips, and runs into the return electrode. During this process, the fat tissue between the needle tips may shrink and retract due to the application of the electrosurgical current via the needle tips.
As used herein, a “bovie” can refer an instrument used for electrosurgical procedures, such as dissection, ablation, and hemostasis. The term “bovie” may also be used as a verb/action, and is frequently used as a synonym for electrocautery (e.g., to bovie a blood vessel). The term “bovie” may also refer to the electrosurgical current that is being applied (e.g., to apply the bovie to the tissue).
In embodiments, an electrosurgical device includes a hand held surgical instrument having a pencil grip type hand-piece. A tip from which the needles extend is connected to the hand-piece and may be angled to improve visualization of the user holding the device. The hand-piece may be selectively separable from the tip, such that a single hand-piece may be reusable with different disposable tips. Alternatively, the hand-piece, tip, and attachment means may be integrally connected as a unit. In either configuration, the tip may be structured and arranged to be selectively rotatable relative to the hand-piece in order to adjust the needle entry into the skin.
The attachment means may include a standard cord that has an appropriate connection to attach to a standard electrosurgical generator unit. Actuation of the electrosurgical current via the needles may be controlled using a foot pedal that is operatively connected to the electrosurgical generator unit. Alternatively, actuation of the electrosurgical current via the needles may be controlled using a button on the hand-piece.
In aspects described herein, the tip may include two needles that are configured to puncture the skin and also serve as electrodes for conveying the electrosurgical current to tissue under the skin. The needles may be very small needles, e.g., on the order of approximately 27-30 gauge, which equals a diameter of about 0.012″ to 0.016″. The needles may have a length of about 0.25″ to 0.5″, and preferably about 1.5 cm. The needles may be insulated on their exterior surfaces except near their respective needle tips (i.e., distal ends) so a current can pass across the needle tips. The insulation may be configured to protect the surrounding tissues during use.
The needles and/or the tip that houses the needles may have a number of additional features. In one aspect, the needles are structured to be movable relative to each other, either translating in a parallel fashion towards or away from each other or actuating in a scissoring fashion towards or away from each other. The relative movement between the needles may be provided and controlled by an actuator that is on the hand-piece. In another aspect, the needles may extend and/or retract from the hand-piece via an actuator on the hand-piece. In additional aspects, the needles may be cooled to help prevent additional damage to surrounding tissues. The cooling may be provided by a heat transfer device in the hand-piece (e.g., a heat sink, forced air cooling device, liquid cooling system, etc.) that is configured to transfer heat away from the needles in order to lower the temperature of the needles. In further aspects, the tip may be configured to oscillate from side to side to increase the coverage during use. In still further aspects, the needles or a second set of needle(s) may provide electrical stimulation to the surrounding muscles to aid in the tightening of the muscles following fat removal.
In accordance with aspects of the invention, a method of using the electrosurgical device includes the following steps. The needles are inserted under the skin in an angled manner directed lateral to medial. The needles are inserted down through the skin and muscle, to the fascial/fat layer. Once appropriate depth is achieved, the bovie (e.g., the electrosurgical current) is applied to the fat. The needles can be slowly withdrawn laterally through a fat section, e.g., along the fascia ridge. If applicable, the needles may oscillate, move apart or be cooled. The needles are then withdrawn from the skin, and moved over laterally to the next section. The previous steps are repeated across the width of the section to be treated.
In accordance with additional aspects of the invention, the electrosurgical device may have only a single needle (rather than two needles) having first and second electrode sections. For example, the single needle may be covered with an electrical insulator, and two separate portions of the needle may be exposed (not covered by the insulator) to provide the respective electrode sections.
In accordance with additional aspects of the invention, the device may include selectively extendable and/or retractable needle(s). For example, a cannula may be provided which houses one or more electrodes in a retracted position. An actuator (e.g., a push button or the like) may be provided to selectively extend the needle(s) out of the retracted position to an extended/exposed position. The needle(s) may be used to apply the electric charge in the manner described herein when in the extended/exposed position. The actuator, or a different actuator, may be used to move the needle(s) from the extended/exposed position back to the retracted position. The device may automatically move the needle(s) from the extended/exposed position back to the retracted position, e.g., by a spring or other mechanism, e.g., when the user releases the actuator. In this manner, the needle(s) are retracted for safety, appearance, etc., when not in use, and selectively extended when it is desired to apply the electric charge to the tissue.
The hand-piece 15 shown in
With continued reference to
As illustrated in
With continued reference to
Still referring to
With continued reference to
The needles 45, 50 may have any suitable size. In an exemplary implementation, the needles 45, 50 have a size on the order of approximately 27-30 gauge, or a diameter of about 0.012″ to 0.016″. The needles may have a length of about 0.25″ to 0.5″, and preferably about 1.5 cm. The needles 45, 50 may be electrically insulated on their exterior surfaces except near their respective needle tips (i.e., distal ends) so a current can pass across the needle tips. The insulation 70 may be configured to protect the surrounding tissues during use. As shown in
According to aspects of the invention, the tip 20 and needles 45, 50 may be configured to provide a user-controlled amount of relative movement between the needles 45, 50 in order to change the treatment area of the device 10. For example, as shown in
In embodiments, the tip 20 and/or the hand-piece 15 is provided with an actuating mechanism that selectively moves the needles 45, 50 between the first position and the second position. In one example, the actuating mechanism comprises a wedge 90 that moves relative to and against the needles 45, 50 when the user squeezes the grips 35, 40 between their finger and thumb. A motion produced by the squeezing action of the grips 35, 40 may be conveyed to the wedge 90 by one or more suitable elements, which may include but are not limited to any one or more of cams, levers, inclined surfaces, gears, etc. When the user releases the squeezing force, the wedge 90 may be resiliently urged back to its initial position, such that the needles 45, 50 automatically return to the first position.
In a particular embodiment, the needles 45, 50 are biased to a first position in which the needles are relatively far apart from one another, and the user may apply an actuating force (e.g., to an actuating mechanism such as that shown in
Embodiments of the invention include an electrosurgical device as described herein. Further embodiments of the invention include a method of manufacturing an electrosurgical device as described herein. Even further embodiments of the invention include a method of performing percutaneous blepharoplasty using an electrosurgical device as described herein.
In accordance with an aspect of the invention, an electrosurgical device as described herein may comprise a hand-held surgical instrument for use in blepharoplasty procedures, wherein the instrument includes: a handle having a long axis; a means by which the handle may be connected to an electrosurgical generator (or RF power supply); and a set of needles partially retained in said handle, and partially extended from one end of the handle. The needles are sized in the 20-30 gauge range, and beveled at the tip to minimize resistance as the tissue is penetrated. The needles taking on a non-linear pathway in the extended region such that they create an obtuse angle with the long axis of the hand-piece. The needles may be insulated along their length, to protect the skin layer through which the needle passes, with a 3-5 mm exposed portion at the distal tip of the needles. The spacing distance between said needles may be adjustable over a range of 2-5 mm. The spacing distance being controlled by an actuation means within the handle. The distal tip of the handle may be pivotable or rotatable such that the orientation of the needles can be adjusted relative to the long axis of the handle.
In accordance with an aspect of the invention, there is a method for aesthetically modifying the eyelid by removal of excess fat tissue using an electrosurgical device as described herein. The method comprises: inserting the needles under the skin in an angled manner directed lateral to medial; the needles are inserted down through the skin and muscle to the fascial/fat layer; once the fat tissue is approximated a current is applied to the needles; the separation distance of the needles is appropriately adjusted to optimize fat removal; with continual current applied, the needles are withdrawn laterally through the fat section; and, once the fat section has been traversed, the current is stopped and the needles are withdrawn.
In accordance with aspects of the invention, there is a percutaneous blepharoplasty electrosurgical device comprising: a hand-piece; a tip connected to the hand-piece; and two needles extending from a distal end of the tip. The hand-piece is structured and arranged to connect to an electrical energy source, and to convey electrical energy from the electrical energy source to the needles in a percutaneous blepharoplasty procedure. In some embodiments, the tip is selectively connectable to and detachable from the hand-piece. In some embodiments, the tip is selectively relative to the hand-piece when the tip is connected to the hand-piece, while electrical continuity is maintained between the tip and the hand piece (see, e.g.,
It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words which have been used herein are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.
Claims
1. A device, comprising:
- a hand-piece;
- a tip at a distal end of the hand-piece; and
- two needles each having a respective free end extending outward from the tip;
- wherein the hand-piece is selectively connectable to an electrical energy source by an attachment that is configured to convey electrosurgical current from the electrical energy source to the hand-piece;
- the hand-piece is configured to convey the electrosurgical current to at least one of the needles;
- the device is adapted to utilize bipolar electrosurgery with one of the needles serving as the active electrode and another one of the needles representing the return electrode,
- the device is adapted such that the electrosurgical current travels through the active electrode, passes through a tissue between the needles, and runs into the return electrode, such that the tissue shrinks and/or retracts as a result of the electrosurgical current;
- the tip is rotatable relative to the hand-piece about an axis that is angled relative to a longitudinal axis of the hand-piece;
- the hand-piece comprises a finger grip and a thumb grip;
- the tip comprises a wedge configured to move relative to and against the needles;
- the wedge is moveable to a first position that causes the needles to be parallel to one another, outside a housing of the tip, and spaced apart by a first distance; and
- the wedge is moveable to a second position that causes the needles to be at an acute angle relative to one another, outside the housing of the tip, and spaced apart by a second distance different than the first distance.
2. A device, comprising:
- a hand-piece;
- a tip at a distal end of the hand-piece; and
- two needles each having a respective free end extending outward from the tip;
- wherein the hand-piece is selectively connectable to an electrical energy source by an attachment that is configured to convey electrosurgical current from the electrical energy source to the hand-piece;
- the hand-piece is configured to convey the electrosurgical current to at least one of the needles;
- the device is adapted to utilize bipolar electrosurgery with one of the needles serving as the active electrode and another one of the needles representing the return electrode,
- the device is adapted such that the electrosurgical current travels through the active electrode, passes through a tissue between the needles, and runs into the return electrode, such that the tissue shrinks and/or retracts as a result of the electrosurgical current;
- the tip is rotatable relative to the hand-piece about an axis that is angled relative to a longitudinal axis of the hand-piece;
- the hand-piece comprises a finger grip and a thumb grip on opposite sides of a generally cylindrical housing;
- the tip comprises a wedge configured to move relative to and against the needles;
- the wedge is configured to move from the first position to the second position based on a squeezing force applied to the finger grip and the thumb grip; and
- the wedge is configured to move from the second position to the first position based on the squeezing force being released.
2032860 | March 1936 | Wappler et al. |
2056377 | October 1936 | Wappler |
3828780 | August 1974 | Morrison, Jr. |
3901242 | August 1975 | Storz |
3920021 | November 1975 | Hilterbrandt |
3920022 | November 1975 | Pastor |
3939839 | February 24, 1976 | Curtiss |
3970088 | July 20, 1976 | Morrison |
4043342 | August 23, 1977 | Morrison, Jr. |
4074718 | February 21, 1978 | Morrison, Jr. |
4116198 | September 26, 1978 | Roos |
4181131 | January 1, 1980 | Ogiu |
4202337 | May 13, 1980 | Hren et al. |
4228800 | October 21, 1980 | Degler, Jr. et al. |
4232676 | November 11, 1980 | Herezog |
4326529 | April 27, 1982 | Doss et al. |
4381007 | April 26, 1983 | Doss |
4476862 | October 16, 1984 | Pao |
4517975 | May 21, 1985 | Garito et al. |
4532924 | August 6, 1985 | Auth et al. |
4548207 | October 22, 1985 | Reimels |
4567890 | February 4, 1986 | Ohta et al. |
4593691 | June 10, 1986 | Lindstrom et al. |
4674499 | June 23, 1987 | Pao |
4682596 | July 28, 1987 | Bales et al. |
4706667 | November 17, 1987 | Roos |
4765331 | August 23, 1988 | Petruzzi et al. |
4805616 | February 21, 1989 | Pao |
4823791 | April 25, 1989 | D'Amelio et al. |
4920978 | May 1, 1990 | Colvin |
4931047 | June 5, 1990 | Broadwin et al. |
4936281 | June 26, 1990 | Stasz |
4943290 | July 24, 1990 | Rexroth et al. |
4966597 | October 30, 1990 | Cosman |
4976711 | December 11, 1990 | Parins et al. |
4998933 | March 12, 1991 | Eggers et al. |
5007908 | April 16, 1991 | Rydell |
5009656 | April 23, 1991 | Reimels |
5047026 | September 10, 1991 | Rydell |
5047027 | September 10, 1991 | Rydell |
5078717 | January 7, 1992 | Parins et al. |
5080660 | January 14, 1992 | Buelna |
5084044 | January 28, 1992 | Quint |
5085659 | February 4, 1992 | Rydell |
5088997 | February 18, 1992 | Delahuerga et al. |
5098431 | March 24, 1992 | Rydell |
5112330 | May 12, 1992 | Nishigaki et al. |
5122138 | June 16, 1992 | Manwaring |
5125928 | June 30, 1992 | Parins et al. |
5143063 | September 1, 1992 | Fellner |
5167659 | December 1, 1992 | Ohtomo et al. |
5171311 | December 15, 1992 | Rydell et al. |
5178620 | January 12, 1993 | Eggers et al. |
5192280 | March 9, 1993 | Parins |
5195959 | March 23, 1993 | Smith |
5196007 | March 23, 1993 | Ellman et al. |
5197466 | March 30, 1993 | Marchosky et al. |
5197963 | March 30, 1993 | Parins |
5207675 | May 4, 1993 | Canady |
5217457 | June 8, 1993 | Delahuerga et al. |
5217459 | June 8, 1993 | Kamerling |
5226904 | July 13, 1993 | Gentelia et al. |
5267994 | December 7, 1993 | Gentelia et al. |
5267997 | December 7, 1993 | Farin et al. |
5273524 | December 28, 1993 | Fox et al. |
5346489 | September 13, 1994 | Levy |
5354296 | October 11, 1994 | Turkel |
5395369 | March 7, 1995 | McBrayer et al. |
5413574 | May 9, 1995 | Fugo |
5514130 | May 7, 1996 | Baker |
D377524 | January 21, 1997 | Lipp |
5626577 | May 6, 1997 | Harris |
5647871 | July 15, 1997 | Levine et al. |
5683385 | November 4, 1997 | Kortenbach et al. |
5709224 | January 20, 1998 | Behl |
5755753 | May 26, 1998 | Knowlton |
5766171 | June 16, 1998 | Silvestrini |
5868744 | February 9, 1999 | Willmen |
5876400 | March 2, 1999 | Songer |
5995875 | November 30, 1999 | Blewett et al. |
6071280 | June 6, 2000 | Edwards et al. |
6117109 | September 12, 2000 | Eggers et al. |
6156035 | December 5, 2000 | Songer |
6193718 | February 27, 2001 | Kortenbach et al. |
6216034 | April 10, 2001 | Hofmann |
6277116 | August 21, 2001 | Utely et al. |
6309387 | October 30, 2001 | Eggers et al. |
6346078 | February 12, 2002 | Ellman et al. |
6395001 | May 28, 2002 | Ellman et al. |
6432105 | August 13, 2002 | Ellman et al. |
6562032 | May 13, 2003 | Ellman et al. |
6610060 | August 26, 2003 | Mulier et al. |
6620156 | September 16, 2003 | Garito et al. |
6632193 | October 14, 2003 | Davison et al. |
6638275 | October 28, 2003 | McGaffigan et al. |
6746447 | June 8, 2004 | Davison et al. |
6749609 | June 15, 2004 | Lunsford et al. |
6772012 | August 3, 2004 | Ricart et al. |
6773431 | August 10, 2004 | Eggers et al. |
6837884 | January 4, 2005 | Woloszko |
6896672 | May 24, 2005 | Eggers et al. |
6920883 | July 26, 2005 | Bessette et al. |
6921398 | July 26, 2005 | Carmel et al. |
7150747 | December 19, 2006 | McDonald |
7198625 | April 3, 2007 | Hui et al. |
7270658 | September 18, 2007 | Woloszko et al. |
7344536 | March 18, 2008 | Lunsford et al. |
7357798 | April 15, 2008 | Sharps et al. |
7384417 | June 10, 2008 | Cucin |
7445619 | November 4, 2008 | Auge, II et al. |
7500974 | March 10, 2009 | Sartor |
7867225 | January 11, 2011 | Heim et al. |
7867226 | January 11, 2011 | Heim et al. |
7892230 | February 22, 2011 | Woloszko |
7896875 | March 1, 2011 | Heim et al. |
7935109 | May 3, 2011 | Cosmescu |
7935110 | May 3, 2011 | Garito et al. |
7935111 | May 3, 2011 | MacDonald |
7935112 | May 3, 2011 | Heim et al. |
7935113 | May 3, 2011 | Heim et al. |
8007493 | August 30, 2011 | McGill et al. |
8083738 | December 27, 2011 | Mirizzi et al. |
8100902 | January 24, 2012 | Sartor |
8103355 | January 24, 2012 | Mulholland |
8133223 | March 13, 2012 | Docimo |
8357154 | January 22, 2013 | Heim et al. |
8357155 | January 22, 2013 | Heim et al. |
8430920 | April 30, 2013 | Li et al. |
20010037107 | November 1, 2001 | Zappala |
20020022870 | February 21, 2002 | Truckai |
20030088243 | May 8, 2003 | Carmel et al. |
20030212396 | November 13, 2003 | Eggers et al. |
20040181214 | September 16, 2004 | Garabedian |
20050222565 | October 6, 2005 | Manstein |
20050245923 | November 3, 2005 | Christopherson et al. |
20060276783 | December 7, 2006 | Cosmescu |
20060293655 | December 28, 2006 | Sartor |
20080071255 | March 20, 2008 | Barthe et al. |
20080319442 | December 25, 2008 | Unger |
20090062792 | March 5, 2009 | Vakharia |
20090124958 | May 14, 2009 | Li |
20090138012 | May 28, 2009 | Sartor |
20090192507 | July 30, 2009 | Luttich |
20090275928 | November 5, 2009 | Solomon et al. |
20100249772 | September 30, 2010 | Mehta et al. |
20110054466 | March 3, 2011 | Rothstein |
20120029498 | February 2, 2012 | Branovan |
20120123412 | May 17, 2012 | Sartor |
20120149990 | June 14, 2012 | Buehler et al. |
20120271294 | October 25, 2012 | Barthe et al. |
Type: Grant
Filed: Jul 17, 2014
Date of Patent: Nov 28, 2017
Patent Publication Number: 20150025604
Inventor: William Thomas McClellan (Morgantown, WV)
Primary Examiner: Daniel Fowler
Application Number: 14/333,910
International Classification: A61B 18/12 (20060101); A61F 9/007 (20060101); A61B 18/00 (20060101); A61B 18/14 (20060101);